Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax ® (Anthrax Vaccine Adsorbed) when administered in conjunction with antibiotics. This non-interference study will be used to support a supplemental Biologics License Application seeking licensure of a Post-Exposure Prophylaxis (PEP) indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax is licensed for a pre-exposure prophylaxis indication only.
“Emergent continues to advance its BioThrax Post-Exposure Prophylaxis program to enhance the clinical utility of BioThrax, the only vaccine licensed by the U.S. Food and Drug Administration for the active immunization against anthrax disease,” said Adam Havey, EVP and president of the biodefense division at Emergent BioSolutions. “Inhalation anthrax is highly lethal when left untreated. Through our partnership with the Biomedical Advanced Research and Development Authority (BARDA), we are exploring how our vaccine can fit in the current PEP treatment regimen, which consists of only oral antibiotics. We remain committed to working in partnership with BARDA to advance critical countermeasures that help ensure the nation’s preparedness.”
The primary objective of this Phase 2, randomized, open label study is to evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic prior to and following the administration of a 3-dose series of BioThrax. The study, which will enroll 120 healthy adult volunteers and is being conducted in multiple sites within the U.S., will also provide additional safety data on the concurrent administration of ciprofloxacin and BioThrax. Preliminary data from this study are expected in the fourth quarter of 2013.
This study is fully funded under contract number HHSO100200700037C provided by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.